FDA Approves Bevacizumab Biosimilar for 5 Cancer Types

The Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev)—a biosimilar for bevacizumab (Avastin) for the treatment of multiple cancer types:

• Metastatic colorectal cancer
• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC)
• Recurrent glioblastoma
• Metastatic renal cell carcinoma
• Persistent, recurrent, or metastatic cervical cancer

“Biosimilars like ZIRABEV can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” said Andy Schmeltz, global president, Pfizer Oncology, the manufacturer of the biosimilar, in a statement. “We are proud to add ZIRABEV to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”

In order to gain FDA approval, biosimilars must prove that they are highly similar to the reference product. This approval was based on a review of a comprehensive data package, including results from the REFLECTIONS B7391003 clinical comparative study, which proved that bevacizumab-bvzr had no clinically meaningful differences to bevacizumab in patients with advanced non-squamous NSCLC.

Bevacizumab-bvzr and its reference product, work by inhibiting new blood cells from forming by binding to the VEGF protein. The biosimilar has been studied in nearly 400 patients so far.

Across the studies and tumor types, the most common adverse events (AEs) for bevacizumab that occurred in 10% or more of patients were: epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis. AEs led to an 8% to 22% discontinuation rate across studies.

“ZIRABEV represents a welcome addition to the treatment armamentarium in its approved indications, potentially providing physicians with a medicine that has a similar safety profile and efficacy as the reference product,” said Niels Reinmuth, MD, PhD, Department of Thoracic Oncology, Asklepios Lung Clinic, Munich-Gauting, Germany, and lead author of the REFLECTIONS B7391003 study. “The FDA’s approval of ZIRABEV may provide an important new option for the treatment of multiple forms of cancer.”